Ocrelizumab

Ocrelizumab Brand Name– OCREVUS

What is Ocrelizumab

Ocrelizumab is an intravenous CD20-directed cytolytic monoclonal antibody that targets and depletes B cells. B cell activation contributes to CNS damage in MS patients.

Ocrelizumab was the first B-cell targeted therapy FDA-approved for MS in adult patients and is used for relapsing forms of primary progressive MS and also for relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

The drug has been shown to reduce risk for relapse and to delay progression of disability.

The efficacy of ocrelizumab for the treatment of primary progressive forms of MS was demonstrated during a placebo-controlled clinical trial, where a 24% risk reduction in the proportion of patients with 12-week confirmed disability progression was observed for patients treated with ocrelizumab (32.9% active drug vs. 39.3% placebo).

The efficacy of ocrelizumab for the treatment of relapsing forms of MS was demonstrated in 2, randomized, double-blind, active comparator trials, in which ocrelizumab was compared to interferon beta-1a.

Across both trials, ocrelizumab significantly reduced annualized relapse rates compared to interferon beta-1a (relative reductions of 46% to 47%) and the proportion of patients with 12-week confirmed disability progression (risk reduction of 40%; 9.8% ocrelizumab vs. 15.2% interferon beta-1a).

Infusion reactions are common; pre-medication is needed prior to infusion to reduce infusion-reaction symptoms.

Indications

  • multiple sclerosis

For the treatment of primary progressive or relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

Side Effects

  1. anaphylactoid reactions
  2. antibody formation
  3. back pain
  4. bronchospasm
  5. cough
  6. depression
  7. diarrhea
  8. dizziness
  9. dyspnea
  10. erythema
  11. fatigue
  12. fever
  13. flushing
  14. headache
  15. hepatitis
  16. hypotension
  17. immunosuppression
  18. infection
  19. infusion-related reactions
  20. laryngeal edema
  21. leukoencephalopathy
  22. meningitis
  23. nausea
  24. neutropenia
  25. new primary malignancy
  26. peripheral edema
  27. progressive multifocal leukoencephalopathy
  28. pruritus
  29. rash
  30. sinus tachycardia
  31. throat irritation
  32. urticaria

Monitoring Parameters

  • hepatitis B serology
  • neurologic function

Contraindications

  • breast cancer
  • breast-feeding
  • contraception requirements
  • hepatitis
  • herpes infection
  • immunosuppression
  • infants
  • infection
  • infusion-related reactions
  • neonates
  • new primary malignancy
  • pregnancy
  • progressive multifocal leukoencephalopathy
  • reproductive risk
  • respiratory infection
  • vaccination
  • viral infection

Interactions

  • Alemtuzumab
  • Anthrax Vaccine
  • Bacillus Calmette-Guerin Vaccine, BCG
  • Belimumab
  • Betamethasone
  • Cortisone
  • Daclizumab
  • Dexamethasone
  • Dimethyl Fumarate
  • Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae type b Conjugate Vaccine; Inactivated Poliovirus Vaccine, IPV
  • Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV
  • Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Inactivated Poliovirus Vaccine, IPV
  • Diphtheria Toxoid; Tetanus Toxoid Adsorbed, DT, Td
  • Diphtheria/Tetanus Toxoids; Pertussis Vaccine
  • Diphtheria/Tetanus Toxoids; Pertussis Vaccine; Haemophilus influenzae type b Conjugate Vaccine
  • Diroximel Fumarate
  • Glatiramer
  • Haemophilus influenzae type b Conjugate Vaccine
  • Haemophilus influenzae type b Conjugate Vaccine; Hepatitis B Vaccine, Recombinant
  • Hepatitis A Vaccine, Inactivated
  • Hepatitis A Vaccine, Inactivated; Hepatitis B Vaccine, Recombinant
  • Hepatitis B Vaccine, Recombinant
  • Human Papillomavirus 9-Valent Vaccine
  • Human Papillomavirus Bivalent Vaccine
  • Human Papillomavirus Quadrivalent Vaccine
  • Hydrocortisone
  • Influenza Virus Vaccine
  • Interferon Beta-1a
  • Interferon Beta-1b
  • Intranasal Influenza Vaccine
  • Japanese Encephalitis Virus Vaccine
  • Live Vaccines
  • Lyme Disease Vaccine
  • Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live
  • Measles/Mumps/Rubella Vaccines, MMR
  • Meningococcal Conjugate Vaccine (MCV4)
  • Meningococcal Group B Vaccine (3 strain)
  • Meningococcal Group B Vaccine (4 strain)
  • Meningococcal Haemophilus influenzae type b Conjugate Vaccine
  • Meningococcal Polysaccharide Vaccine (MPSV4)
  • Methylprednisolone
  • Mitoxantrone
  • Monomethyl Fumarate
  • Natalizumab
  • Non-Live Vaccines
  • Ozanimod
  • Peginterferon beta-1a
  • Pneumococcal Vaccine, Polyvalent
  • Poliovirus Vaccine, Inactivated, IPV
  • Prednisolone
  • Prednisone
  • Rabies Vaccine
  • Rituximab
  • Rituximab; Hyaluronidase
  • Rotavirus Vaccine
  • Rubella Virus Vaccine Live
  • Smallpox and Monkeypox Vaccine, Live, Nonreplicating
  • Smallpox Vaccine, Vaccinia Vaccine
  • Teriflunomide
  • Tetanus Toxoid
  • Triamcinolone
  • Typhoid Vaccine
  • Varicella-Zoster Virus Vaccine, Live
  • Yellow Fever Vaccine, Live
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